China’s State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for these devices. All of these regulations have been marked as interim and could be subject to change. SFDA also issued notices on standardizing the production quality management systems and supervision and inspection of these devices.
For non-sterile/implantable medical devices, SFDA has formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim). These regulations will standardize quality management systems, intensify supervision on manufacturing, and strengthen the management of medical device GMP inspection.
The Good Manufacturing Practice for Medical Devices (interim) is made of 13 chapters, 69 articles and will take effect as of January 1, 2011. The 13 chapters include management responsibilities, files and record requirements, design and development, manufacturing management, inspections, sales and services, adverse events, etc. Manufacturers must demonstrate they have appropriate documentation and SOPs in place for quality control and after-sales service.
GMP compliance would be required for Class II and III devices. In addition, manufacturers will also be subject to an on-site GMP audit if it is their first time applying or for re-registration.
The SFDA first started discussions on medical device GMP certification in 2004. The first GMP rules were set up in 2005 with a trial period to determine feasibility.
These new GMP regulations for both regular and sterile/non-implantable medical devices will mostly likely be revised and made effective as of January 2011.